1 PRODUCT AND COMPANY IDENTIFICATION 1.1 Product identifiers Product name and number Exonuclease RM2 Safety Data Sheet 1.2 Relevant identified uses of the substance or mixture and used advised against Identified uses In vitro diagnosic use, investigational use and for research use 1.3 Details of the supplier of the safety data sheet Company GenMark Diagnostics 5964 La Place Court Carlsbad, CA 928 Telephone +1 8-373-6767 +1 76-448-43 1.4 Emergency telephone number 1-8-424-93 2 HAZARD IDENTIFICATION 2.1 Classification of the substance or mixture This chemical is not considered hazardous according to the OSHA Hazard Communication Standard 212 (29 CFR 191.12). 2.2 GHS label elements ne 2.3 Hazards not otherwise classified or not covered by GHS ne 3 COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances The product contains no substances which at their given concentration, are considered to be hazardous to health. 4 FIRST AID MEASURES 4.1 Description of first aid measures If inhaled If breathed in, move person into fresh air. If not breathing, give artificial respiration. In case of skin contact Wash off with soap and plenty of water. In case of eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 4.2 Most important symptoms and effects both acute and delayed The most important known symptoms and effects are described in the labelling (see section 2.2) and/or in section 11 4.3 Indication of any immediate medical attention and special treatment needed data available MSDS1 Rev. A Page 1 of 6
5 FIRE-FIGHTING MEASURES 5.1 Extinguishing media Suitable extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide 5.2 Special hazards arising from the substance or mixture Hydrogen chloride gas, Sodium oxides, carbon oxides, nitrogen oxides (NOx) 5.3 Advice for firefighters Wear self contained breathing apparatus for fire fighting if necessary. Safety Data Sheet 6 ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. For personal protection see section 8. 6.2 Environmental precautions Prevent further leakage or spillage if safe to do so. Do not let product enter drains. 6.3 Methods and material for containment and cleaning up Keep in suitable, closed containers for disposal. 6.4 Reference to other sections For disposal see section 13. 7 HANDLING AND STORAGE 7.1 Precautions for safe handling Avoid contact with skin and eyes. Avoid inhalation of vapour or mist. For precautions see section 2.2. 7.2 Conditions for safe storage, including any incompatibilities Keep container tightly closed in a dry and well-ventilated place. 7.3 Specific end use(s) Apart from the uses mentioned in section 1.2 no other specific uses are stipulated. 8 EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters Components with limit values that require monitoring at the workplace Contains no substances with occupational exposure limit values. 8.2 Exposure controls Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. 8.3 Individual protection measures, such as personal protective equipment (PPE) Eye/face protection Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good MSDS1 Rev. A Page 2 of 6
laboratory practices. Wash and dry hands. Body Protection Complete suit protecting against chemicals. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Respiratory protection Where risk assessment shows air-purifying respirators are appropriate use a full-face particle respirator type N1 (US) or type P3 (EN 143) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Control of environmental exposure Prevent further leakage or spillage if safe to do so. Do not let product enter drains. 9 PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties Appearance Form: liquid Color: colorless Odor Odor Threshold ph Melting point/freezing point Initial boiling point and boiling range Flash point Evapouration rate Flammability (solid, gas) Upper/lower flammability or explosive limits Vapour pressure Vapour density Relative density Water solubility Partition coefficient: n- octanol/ water Auto-ignition temperature Decomposition temperature Viscosity Oxidizing properties 9.2 Other safety information 1 STABILITY AND REACTIVITY 1.1 Reactivity data available 1.2 Chemical stability Stable under recommended storage conditions. 1.3 Possibility of hazardous reactions data available 1.4 Conditions to avoid data available 1.5 Incompatible materials MSDS1 Rev. A Page 3 of 6
Strong oxidizing agents 1.6 Hazardous decomposition products Other decomposition products - In the event of fire: see section 5 11 TOXICOLOGICAL INFORMATION 11.1 Information on likely routes of exposure Product Information Product does not present an acute toxicity hazard based on known or supplied information. Inhalation Eye Contact Skin Contact Ingestion There is for this product. There is for this product. There is for this product. There is for this product. 11.2 Symptoms related to the physical, chemical and toxicological characteristics Symptoms ne known 11.3 Delayed and immediate effects and also chronic effects from short and long term exposure Sensitization information available. Mutagenic Effects information available Carcinogenicity Contains no ingredients above reportable quantities listed as a carcinogen. Reproductive Toxicity information available. STOT - single exposure information available. STOT - repeated exposure information available. Aspiration Hazard information available. 12 ECOLOGICAL INFORMATION 12.1 Toxicity 12.2 Persistence and degradability 12.3 Bioaccumulative potential 12.4 Mobility in soil 12.5 Results of PBT and vpvb assessment PBT/vPvB assessment not available as chemical safety assessment not required/not conducted 12.6 Other adverse effects 13 DISPOSAL CONSIDERATION 13.1 Disposal methods This material, as supplied, is not a hazardous waste according to Federal regulations (4 CFR 261). This material could become a hazardous waste if it is mixed with or otherwise comes in contact with a hazardous waste, if chemical additions are made to this material, or if the material is processed or otherwise altered. Consult 4 CFR 261 to determine whether the altered material is a hazardous waste. Consult the appropriate state, regional, or local regulations for additional requirements. MSDS1 Rev. A Page 4 of 6
14 TRANSPORT INFORMATION IATA, ADR, DOT 14.1 UN Number t a dangerous good in sense of these transport regulations. 14.2 UN Proper shipping name ne 14.3 Transport hazard class(es) ne 14.4 Packing group ne 14.5 Additional information ne 15 REGULATORY INFORMATION 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture International Inventories TSCA Complies DSL Sustances comply or are exempt Legend TSCA - United States Toxic Substances Control Act Section 8(b) Inventory DSL/NDSL - Canadian Domestic Substances List/n-Domestic Substances List U.S. Federal Regulations Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any chemicals which are subject to the reporting requirements of the Act and Title 4 of the Code of Federal Regulations, Part 372. SARA 311/312 Hazard Categories Acute Health Hazard Chronic Health Hazard Fire Hazard Sudden Release of Pressure Hazard Reactive Hazard Clean Water Act This product does not contain any substances regulated as pollutants pursuant to the Clean Water Act (4 CFR 122.21 and 4 CFR 122.42). CERCLA This material, as supplied, does not contain any substances regulated as hazardous substances under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA) (4 CFR 32) or the Superfund Amendments and Reauthorization Act (SARA) (4 CFR 355). There may be specific reporting requirements at the local, regional, or state level pertaining to releases of this material. U.S. State Regulations California Proposition 65 This product does not contain any Proposition 65 chemicals. U.S. State Right-to-Know Regulations This product does not contain any substances regulated by state right-to-know regulations. U.S. EPA Label Information EPA Pesticide Registration Number: t applicable 16 OTHER INFORMATION HMIS Rating Health hazard: 1 MSDS1 Rev. A Page 5 of 6
Chronic Health Hazard: Flammability: Physical Hazard: NFPA Rating Health hazard: Fire Hazard: Reactivity Hazard: * 1 General Disclaimer The information provided herein is correct to the best of our knowledge, information and belief at the date of its publication. The information provided is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. We make no warranty, express or implied, with respect to such information and we assume no liability as a result of its use. Users should make their own investigation to determine the suitability of this information for their particular purposes and must make their own determination of the effects, properties, protections and disposal which pertain to their particular conditions. GenMark Diagnostics, Inc. shall not be held liable for any damage or losses resulting from the handling, use, storage or disposal of or contact with this product. eplex TM, esensor, GenMark, GenMark Dx and XT-8 are trademarks of GenMark Diagnostics, Inc. End of Safety Data Sheet MSDS1 Rev. A Page 6 of 6